This invention relates to an improved tissue expander and stent for use in the reconstruction of a nipple in a human breast and to a method for splinting the reconstructed nipple.
Over the last few years, nipple-areola reconstruction in female patients has been greatly improved by new surgical techniques. And today, the surgeon is able to reconstruct a symmetrical areolar complex with an excellent projecting nipple. For example, the subcutaneous pedicle technique with splinting can be used to produce an extremely natural appearing nipple which remains elevated about 1 cm. above the areola. Such procedures have been described, for example, by Dale B. Dubin, M.D. in an as yet unpublished article, "A New Simplified Method for Nipple Reconstruction," a copy of which is being provided to the examiner. That procedure and the splint disclosed by Dubin are described below.
In performing these surgical procedures, a surgeon makes a circular incision in the breast, places a rigid or semi-rigid tubular splint on the breast with the circular incision surrounded by the tubular splint. The patient's tissue expands upwardly into the tubular splint and the flap of skin, i.e. the skin which covers the area of tissue within the circular incision, is sutured to the splint. The splint is then left in place for a period of two (2) or more weeks. Then after healing, the stitches and splint are removed.
Dubin disclosed the use of a circular cap from the container of a 35 cc Monoject disposable syringe (obtained from Monoject of St. Louis, MO) as a stent. The center of the flat portion of the relatively rigid cap was cut out with a hot tip cautery. Then four vertical 4 mm slits were made with a #15 blade every 90.degree. along the edge of the plastic cap. The flat side of the modified cap was then placed on the breast of a patient with the reconstructed nipple extending upwardly through the hole and with the circular portion of the cap extending upwardly from the breast and surrounding the nipple. Four nylon sutures placed just below the dermis of the nipple were brought through the hole in the cap before the cap was placed on the patient's breast. The nipple was pulled vertically and the nylon sutures were secured in the slits along the edge of the cap. The nylon sutures were then taped along the outside edge of the surrounding wall with adhesive tape.
The use of rigid tubular splints can cause patient discomfort and at times loss of tension in the sutures during the healing process. In addition, the small tubular splints may be relatively difficult to handle and position during surgery and do not promote tissue expansion to the degree desired.
An improved tissue expander and stent according to the present invention reduces patient discomfort and enhances tissue expansion. In addition, the stent is easier to position and suture in place, and therefore facilitates the surgical techniques.
The improved tissue expander and stent disclosed herein is made of soft, pliable and resilient material, is readily sutured in place, and at the same time reduces or eliminates any likelihood of the sutures being pulled through the soft pliable material without adding to the patient's discomfort.
In addition, the improved stents disclosed herein can be manufactured at a relatively low cost, are readily sterilized and can be readily packaged and shipped in a sterile condition.